Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03599713
Registration number
NCT03599713
Ethics application status
Date submitted
16/07/2018
Date registered
26/07/2018
Date last updated
11/04/2024
Titles & IDs
Public title
A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
Query!
Scientific title
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)
Query!
Secondary ID [1]
0
0
INCMGA 0012-201
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Merkel Cell Carcinoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Malignant melanoma
Query!
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Retifanlimab
Experimental: Retifanlimab: Chemotherapy: Naïve -
Experimental: Retifanlimab: Chemotherapy: Refractory -
Treatment: Drugs: Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [1]
0
0
ORR was defined as the percentage of participants with a confirmed overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by Independent Central Radiographic Review (ICR), at any post-Baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Query!
Timepoint [1]
0
0
up to 26.8 months
Query!
Secondary outcome [1]
0
0
Duration of Response (DOR)
Query!
Assessment method [1]
0
0
DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until PD, or death due to any cause, as determined by ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. A Kaplan-Meier estimate (estimated median) of the distribution function is reported.
Query!
Timepoint [1]
0
0
up to 24.9 months
Query!
Secondary outcome [2]
0
0
Disease Control Rate (DCR)
Query!
Assessment method [2]
0
0
DCR was defined as the percentage of participants with a confirmed overall response (CR and PR) or stable disease (SD) (non-CR/non-PD) lasting at least 6 months from the start of treatment, until the first PD or new anti-cancer therapy, per RECIST v1.1 as determined by ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Query!
Timepoint [2]
0
0
up to 26.8 months
Query!
Secondary outcome [3]
0
0
Progression-free Survival (PFS)
Query!
Assessment method [3]
0
0
According to RESIST v1.1, PFS was defined the time from the start of therapy until disease progression, or death due to any cause, as determined by ICR. Evaluation of target lesions: PD: =20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered PD). Evaluation of non-target lesions: PD: Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered PD).
Query!
Timepoint [3]
0
0
up to 26.8 months
Query!
Secondary outcome [4]
0
0
Overall Survival
Query!
Assessment method [4]
0
0
Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.
Query!
Timepoint [4]
0
0
up to 33.9 months
Query!
Secondary outcome [5]
0
0
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Query!
Assessment method [5]
0
0
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as either an AE reported for the first time or a worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. An AE with onset on/after starting a new anticancer therapy was not summarized as a TEAE.
Query!
Timepoint [5]
0
0
up to 823 days (up to approximately 2.3 years)
Query!
Secondary outcome [6]
0
0
First-dose Cmax of Retifanlimab
Query!
Assessment method [6]
0
0
Cmax was defined as the maximum observed plasma concentration.
Query!
Timepoint [6]
0
0
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
Query!
Secondary outcome [7]
0
0
First-dose Cmin of Retifanlimab
Query!
Assessment method [7]
0
0
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Query!
Timepoint [7]
0
0
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
Query!
Secondary outcome [8]
0
0
First-dose AUC0-t of Retifanlimab
Query!
Assessment method [8]
0
0
AUC0-t was defined as the area under the plasma concentration-time curve from time zero to time t.
Query!
Timepoint [8]
0
0
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
Query!
Eligibility
Key inclusion criteria
- Signed informed consent.
- Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional
disease not amenable to surgery or radiation
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Measurable disease according to RECIST v1.1.
- Availability of tumor tissue (fresh or archival) for central pathology review.
- Willingness to avoid pregnancy or fathering children based on protocol-defined
criteria.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or
PD-L1-directed therapy.
- Treatment with anticancer drugs or participation in another interventional clinical
study within 21 days before the first administration of study drug.
- Has not recovered to = Grade 1 or baseline from toxic effects of prior therapy (with
the exceptions for anemia not requiring transfusion support and any grade of alopecia)
and/or complications from prior surgical intervention within 7 days before starting
study treatment.
- Radiation therapy administered within 2 weeks of first dose of study treatment or
radiation therapy to the thoracic region that is > 30 Gy within 6 months of the first
dose of study treatment.
- Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- History of second malignancy within 3 years (with exceptions).
- Laboratory values outside the protocol-defined range at screening.
- Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
- Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
- Receipt of a live vaccine within 28 days of planned start of study therapy.
- Current use of protocol-defined prohibited medication.
- Known hypersensitivity to another monoclonal antibody that cannot be controlled with
standard measures (eg, antihistamines and corticosteroids).
- Inability or unlikely, in the opinion of the investigator, to comply with the Protocol
requirements.
- Participant who is pregnant or breastfeeding.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/02/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
28/06/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
107
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
St Vincent'S Hospital Sydney - Darlinghurst
Query!
Recruitment postcode(s) [1]
0
0
02010 - Darlinghurst
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Minnesota
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Jersey
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Virginia
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Washington
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
West Virginia
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Alberta
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
CA
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Ontario
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Quebec
Query!
Country [18]
0
0
Czechia
Query!
State/province [18]
0
0
Olomouc
Query!
Country [19]
0
0
Czechia
Query!
State/province [19]
0
0
Praha 4-krc
Query!
Country [20]
0
0
Czechia
Query!
State/province [20]
0
0
Praha
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Boulogne-billancourt
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Marseille Cedex 5
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Nantes Cedex
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Nice Cedex 3
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Paris
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Rouen
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Villejuif Cedex
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Berlin
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Buxtehude
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Erfurt
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Essen
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Kiel
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Marburg
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Regensburg
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Tubingen
Query!
Country [36]
0
0
Hungary
Query!
State/province [36]
0
0
Budapest
Query!
Country [37]
0
0
Hungary
Query!
State/province [37]
0
0
Debrecen
Query!
Country [38]
0
0
Hungary
Query!
State/province [38]
0
0
Szeged
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Bari
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Candiolo
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Genova
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Milan
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Modena
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Naples
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Padova
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Rome
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Siena
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Warsaw
Query!
Country [49]
0
0
Spain
Query!
State/province [49]
0
0
Barcelona
Query!
Country [50]
0
0
Spain
Query!
State/province [50]
0
0
Madrid
Query!
Country [51]
0
0
Switzerland
Query!
State/province [51]
0
0
Lausanne
Query!
Country [52]
0
0
Switzerland
Query!
State/province [52]
0
0
Zuerich
Query!
Country [53]
0
0
United Kingdom
Query!
State/province [53]
0
0
Cottingham
Query!
Country [54]
0
0
United Kingdom
Query!
State/province [54]
0
0
London
Query!
Country [55]
0
0
United Kingdom
Query!
State/province [55]
0
0
Sutton
Query!
Country [56]
0
0
United Kingdom
Query!
State/province [56]
0
0
Truro
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Incyte Corporation
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in
participants with advanced/metastatic Merkel cell carcinoma (MCC).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03599713
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Incyte Medical Monitor
Query!
Address
0
0
Incyte Corporation
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03599713
Download to PDF